Chemotherapy In Elderly Patients Research Articles

Clearance of leukemic blasts by flow cytometry versus minimal residual disease as predictors of clinical outcome in elderly patients with acute myeloid leukemia.

e19514 Background: Lower-intensity regimens, such as hypomethylating agents (HMAs) are better tolerated and more effective than standard chemotherapy in elderly patients( > 65 years old) with acute myeloid leukemia (AML). Scoring systems to predict clinical outcome in these patients are mainly based on cytogenetic assays and morphological response to therapy. Minimal residual disease (MRD) represents a powerful risk- stratification in younger AML patients but it remains poorly investigated in older patients, particularly in those undergone HMAs. In this subset, the survival benefit is not limited to patients achieving morphologic complete remission (CR). The clearance of leukemic blasts was never be valued as a predictive parameter of outcome in older patients. Thus, in this study we evaluated the most effective and predictive factor of outcome at the optimal time-point among leukemic blasts clearance by flow cytometry (FC), MRD and morphological response in older patients treated with HMAs. Methods: From april 2015 to may 2019, 76 older patients ( > 60 years old) with newly diagnosed AML were treated con azacitidine and decitabine. Among them, 56 completed at least six cycles but 31were properly monitored by FC. Log Clearance was defined as logarithmic ratio between the percentage of blast cells at specific time point and that at the diagnosis. Results: A total of 31 elderly patients with a median age 72 (60-85) were evaluated after 4(T4) and 6(T6) cycles of HMAs. A Median of 10 cycles were administered, equally distributed between azacitidine and decitabine. A higher frequency of CR (73.3%vs 20%) and MRD negativity (16.6% vs 0) was found at T6 compared to T4, thus T6 was chosen for the analysis. Performance status (PS > 2),Hgb < 10 g/dl, MRD positivity and a Log-reduction lower than 2 log predicted a significantly shorter DFS at univariate analysis. However, Log-reduction and PS only confirmed to predict a short DFS also at multivariate analysis, together with CRi (CR with incomplete recovery) and partial remission (PR). When the OS was investigated, only PS represented a strong indicator of prognosis at both univariate and multivariate analysis. Conclusions: Our results suggest that patients achieving 2 Log at least of blasts-reduction by FC had a longer DFS. Dynamic monitoring of blast –reduction stratified better and more widely than the absolute value of MRD in older AML patients. Having a high PS and achieving a CRi instead of a CR showed an unfavorable outcome in terms of both DFS and OS

First-line biological agents plus chemotherapy in elderly patients with metastatic colorectal cancer: A retrospective pooled analysis.

4017 Background: Biological agents, in combination with chemotherapy, are recommended as first-line treatment of metastatic colorectal cancer (mCRC); however, evidence guiding appropriate management of elderly patients with mCRC is lacking. This study compared the efficacy and safety outcomes in older versus younger patients with mCRC who received first-line biological therapy. Methods: This retrospective analysis used pooled data from five Spanish TTD collaborative group studies of adults with advanced CRC who received first-line treatment with bevacizumab, cetuximab or panitumumab, stratified by age (≥65 vs < 65 years). Endpoints included progression-free survival (PFS), overall survival (OS), overall response rate (ORR) and safety. Results: In total, 999 patients from five studies were included in the analysis; 480 (48%) were aged ≥65 years and 519 (52%) were aged < 65 years; 733 (73.37%) were treated with bevacizumab, 189 (18.92%) received cetuximab and 77 (7.71%) received panitumumab. Median PFS did not significantly differ between patients aged ≥65 versus < 65 years (9.9 vs 9.4 months; hazard ratio [HR] 1.01; 95% confidence interval [CI] 0.88–1.17). Median OS was significantly shorter in older versus younger patients (21.3 vs 25.0 months; HR 1.21; 95% CI 1.04–1.41; P = 0.0132). There was no significant difference between older versus younger patients in ORR (59% vs 62%). Older patients experienced more treatment-related grade ≥3 adverse events. Conclusions: Biological agents are an effective first-line treatment option for elderly patients with mCRC, with comparable efficacy in PFS and ORR to that observed in younger patients and a manageable safety profile.

Survival Benefit of Combination Chemotherapy in Elderly Patients With Metastatic Pancreatic Ductal Adenocarcinoma.

Survival benefit of combination over single-agent chemotherapy for metastatic pancreatic ductal adenocarcinoma (PDAC) was demonstrated in younger patients in clinical trials. The authors aimed to evaluate whether this survival benefit of combination chemotherapy is present in elderly patients with metastatic PDAC. The authors identified elderly patients (age 65 y or older) with stage IV PDAC and extracted available clinical information from a prospectively maintained institutional pancreatic cancer registry from 2007 to 2016. The primary endpoint was overall survival. Cox proportional hazards regression was used for multivariable survival analyses. Survival outcomes for the entire cohort and by age group I (elderly, 65 to 75 y) and age group II (very elderly, older than 75 y) were assessed. A total of 606 patients were included with a median age of 73.8 years. Among them, 239 patients (39%) received combination chemotherapy and 152 patients (25.1%) received single-agent chemotherapy as first-line treatment. Combination chemotherapy was associated with significantly longer median overall survival compared with single-agent chemotherapy (10.9 vs. 7.5 mo, P<0.001) with hazard ratio 0.62 (95% confidence interval, 0.47-0.81; P=0.001) after adjusting for age, sex, comorbidity, Eastern Cooperative Oncology Group (ECOG) performance status, and carbohydrate antigen 19-9 level. Analyses by age groups indicated that very elderly patients (age group II) benefited from combination chemotherapy compared with single-agent chemotherapy with hazard ratio 0.56 (95% confidence interval, 0.31-1; P=0.049), comparable with the age group I (Page-treatment interaction=0.81). Elderly patients, even those older than 75 years, with metastatic PDAC benefited from combination chemotherapy.

Clinical significance of serum cystatin C in early evaluation of renal impairment caused by chemotherapy in elderly patients.

BackgroundThis study aims to discuss the application value of serum cystatin C (Cys C) in detecting early renal function injury in elderly patients with malignant tumors after chemotherapy.MethodsThe data at different chemotherapy time points (before chemotherapy, after two cycles of chemotherapy, and after four cycles of chemotherapy) were analyzed.ResultsSerum Cys C was significantly higher after chemotherapy than before chemotherapy in elderly patients with malignant tumors, and the endogenous creatinine clearance rate (CCr) significantly decreased. These were significantly correlated. However, there was no significant change in serum creatinine (SCr) and blood urea nitrogen (BUN). Cys C continued to increase with the prolonged time of chemotherapy. In addition, Cys C was sensitive for detecting renal impairment caused by platinum-based chemotherapy drugs.ConclusionsThe diagnostic effect of Cys C on early renal function injury after chemotherapy in elderly patients with malignant tumors is better, when compared to traditional renal function test items, such as SCr, BUN and CCr.

Post-remission therapy of adults aged 60 and older with acute myeloid leukemia in first complete remission: role of treatment intensity on the outcome.

Although complete remission (CR) is achieved in 50 to 70% of older fit patients with acute myeloid leukemia (AML), consolidation therapy in this age group remains challenging. In this retrospective study, we aimed to compare outcome in elderly patients treated with different post-remission modalities, including allogenic and autologous hematopoietic stem cell transplantation (HSCT), intensive chemotherapy, and standard-dose chemotherapy (repeated 1 + 5 regimen). We collected data of 441 patients ≥ 60years in first CR from a single institution. Median age was 67years. Sixty-one (14%) patients received allo-HSCT, 51 (12%) auto-HSCT, 70 (16%) intensive chemotherapy with intermediate- or high-dose cytarabine (I/HDAC), and 190 (43%) 1 + 5 regimen. Median follow-up was 6.5years. In multivariate analysis, allo-HSCT, cytogenetics, and PS had a significant impact on OS and LFS. In spite of a more favorable-risk profile, the patients who received I/HDAC had no significantly better LFS as compared with patients treated with 1 + 5 (median LFS 8.8months vs 10.6months, p = 0.96). In transplanted patients, median LFS was 13.3months for auto-HSCT and 25.8months for allo-HSCT. Pre-transplant chemotherapy with I/HDAC had no effect on the outcome. Toxicity was significantly increased for both transplanted and non-transplanted patients treated with I/HDAC, with more units of blood and platelet transfusion and more time spent in hospitalization, but no higher non-relapse mortality. This study shows that post-remission chemotherapy intensification is not associated with significantly better outcome as compared with standard-dose chemotherapy in elderly patients for whom, overall results remain disappointing.

Abstract P6-11-16: Survey on attitude towards treatment recommendations for elderly patients with breast cancer

Abstract Background: With the rapid aging of the society, breast cancer in elderly people is also increasing. Although it is important to avoid unnecessary toxicity to maintain the quality of life of elderly patients, it is suggested that they are undertreated compared to younger counterparts which leads to poorer outcomes. The objective of this study was to assess the practice of the clinical care for elderly breast cancer patients aged 75 or over, and to explore the factors associated with physicians’ attitude regarding treatment recommendations towards elderly breast cancer patients in Japan. Methods: We conducted an online survey towards 1690 Breast Care Specialists belonging to the Japanese Breast Cancer Society. The respondents were asked to complete a questionnaire including (1) sociodemographic background, (2) hypothetical case scenarios in patients with Stage IIB breast cancer, (3) clinical experience of elderly breast cancer patients, (4) Good Death Inventory (GDI), a measure for evaluating good death from the bereaved family member's perspective and (5) belief regarding cancer treatment for elderly breast cancer patients. We used descriptive statistics to summarize respondents' sociodemographic data. Chi-square tests were used to evaluate differences in proportion. Differences in GDI scores were estimated using Mann-Whitney tests. Statistical analyses were performed using SPSS software. Results: 508 (30%) physicians responded to the survey. 353 (69.4%) were male. 464 (91.3%) were breast surgeons and 43 (8.4%) were others, including medical oncology, radiology and general surgery. 46 (9%), 115 (22.6%), 284 (55.9%) and 47 (9.3%) belonged to cancer centers, university hospitals, general hospitals and clinics, respectively. 136 (26.8%) of the physicians responded that they have a specialized department or a team which serve for elderly patients in their institutions, whereas 369 (72.6%) answered there was no such support. In questions based on hypothetical case scenarios, significantly more physicians responded that they would not recommend chemotherapy in a 78 year-old with luminal-type breast cancer, good performance status (PS) and no complications compared to a 55 year-old with the same clinical status (p&amp;lt;0.001). Physicians who would recommend chemotherapy significantly decreased in a clinical scenario of a 78 year-old with the same clinical stage and subtype but with a lower PS and some complications (p&amp;lt;0.001). More physicians recommended chemotherapy in a 78 year-old with HER2 type tumor compared to a patient with luminal type tumor when the PS and complication status were the same (p&amp;lt;0.001). The respondents’ GDI Scores were not related to the treatment recommendations in any clinical scenario. Physicians who treated larger number of outpatients per day and those who had lower proportion of elderly patients in the clinic tended not to recommend chemotherapy for elderly patients with poorer PS and serious complications. Those who believed that “it is a doctor’s responsibility not to pursue aggressive chemotherapy in elderly patients” tended not to recommend chemotherapy in a 78-year-old patient with luminal type breast cancer with good PS and without complication. Conclusions: The attitude towards treatment recommendation on adjuvant chemotherapy in elderly breast cancer patients were related to performance status, complications and subtype of the tumor. Physicians’ experience and belief may also affect their attitude. Citation Format: Kanako Nakayama, Chikako Shimizu, Keiko Iino, Shigeaki Watanuki, Masataka Sawaki. Survey on attitude towards treatment recommendations for elderly patients with breast cancer [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P6-11-16.

Abstract P2-16-34: Patterns of survival and efficacy of chemotherapy in elderly patients with triple-negative breast cancer treated in the neoadjuvant setting

Abstract Background. Triple negative breast cancer (TNBC) is the most aggressive molecular subtype. It is mostly observed in younger patients, however, substantial proportion of patients are above age of 60. Despite that, this group of patients was not studied and analyzed separately in previous studies. Objectives. To establish efficacy of neoadjuvant chemotherapy in elderly patients with stage II-III TNBC and patterns of progression for this group of patients. Methods. Since 2014 we treated 92 patients with histologically confirmed stage II-III TNBC. Neoadjuvant therapy included 6 cycles of Cisplatin 75mg/m2 day 1 and Paclitaxel 80mg/m2 days 1, 8, 15, every 4 weeks according to local protocol. After neoadjuvant chemotherapy patients proceeded to radical breast surgery with assessing pathological response. Then we analyzed clinical characteristics of patients and their survival according to the pathological response achieved. Results. In our analysis were included 92 patients, 22 of them were elderly patients (above 60). Pathological complete response was achieved in 57,6% of all patients. In the elderly group we observed significantly higher proportion of tumors with advanced stages (N3: 40,9% vs 20,0%, p&amp;lt;0.05, locally advanced: 77,3% vs 51,4%, p&amp;lt;0.05). Although not clinically significant, elderly patients less frequently achieved complete clinical response (28,6% vs 41,4%). Pathologic complete response was achieved in 52,6% of elderly patients and in 71,7% of younger patients (p&amp;lt;0.05). Higher proportion of patients above 60 experienced nephrotoxicity (54,5% vs 17,1%, p&amp;lt;0.05) and peripheral polyneuropathy (22,7% vs 17,1%, p=0.054). In this group of patients only 22,7% completed all 6 cycles as opposed to 65,7% of younger patients (p&amp;lt;0.05). Higher proportion of elderly patients had local recurrence: 45,5% vs 22,9% (p&amp;lt;0.05), visceral metastases: 36,4% vs 17,1% (p&amp;lt;0.05). We observed tendency for this group of patients to have liver and lungs as first sites of metastases (80%), as opposed to younger patients, for whom CNS was the most frequent first metastatic site (50%). To the date of cut-off (June 2019) 17 patients died, all of them due to the progression of the disease (31,8% in elderly group, 14,3% in younger group). Survival outcomes are presented in table below. Table 1. Survival outcomes.SurvivalBelow 60 y.o.Above 60 y.o.Recurrence-free survival&amp;lt;0.053 years73,7%61,9%5 years69,6%51,6%Survival without distant metastases&amp;lt;0.053 years78,9%68,6%5 years74,6%57,2%Overall survival0,0573 years81,8%72,4%5 years77%54,3% Conclusion. In our analysis elderly patients with early and locally advanced TNBC demonstrate decreased response, another safety profile and lower survival rates. Different efficacy could be explained with lower number of cycles of neoadjuvant chemotherapy administered and more advanced stages upon presentation. Different metastatic patterns which we observed in younger and elderly patients should be further studied. Citation Format: Olga Gordeeva, Irina Kolyadina, Lyudmila Zhukova, Inna Ganshina, Dmitry Komov, Andrey Meshcheryakov. Patterns of survival and efficacy of chemotherapy in elderly patients with triple-negative breast cancer treated in the neoadjuvant setting [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P2-16-34.

Abstract P2-14-05: Adjuvant chemotherapy in elderly women with triple-negative breast cancer: Swedish registry data 2009-2017

Abstract Background: Breast cancer incidence is strongly related to age, with the highest incidence rates being in elderly women. Triple-negative breast cancer (TNBC) is an aggressive form of breast cancer associated with worse survival. Due to competing mortality risks and co-morbidities, TNBC in the elderly is often under-treated with adjuvant chemotherapy. The aim of this study was to investigate if there is a gain in both breast cancer specific survival (BCSS) and overall survival (OS) with adjuvant chemotherapy in elderly patients with TNBC. Method: Information from all patients 70 years and older diagnosed with primary TNBC during the years 2009-2017 were retrieved from the Swedish National Register for Breast Cancer, the Swedish Cause of Death Register and the Swedish Patient Register. Both a propensity score matched (PSM) model and a Cox-regression model was created examining the effect of age, tumor size, tumor grade, nodal status, co-morbidities (Charlson/Deyo) and chemotherapy treatment, on BCSS and OS. Results: Of the 1421 patients included, 428 (30.1%) received chemotherapy. The 5-year BCSS was 84% vs. 62% in favor for patients receiving chemotherapy. The 5-year OS was 80% vs. 46% in favor for patients receiving chemotherapy. When adjusting for the co-variates using PSM, the 5-year BCSS was 84% vs. 73% (p&amp;lt;0.004) and the 5-year OS was 79% vs. 62% (p&amp;lt;0.001) favoring chemotherapy. Discussion: In this PSM registry analysis including all patients ≥70 years in Sweden with TNBC during a 9-year period, we could show that there was a significant benefit in both BCSS and OS with adjuvant chemotherapy when adjusting for both age and co-morbidities. Cox multivariate regression model for breast cancer specific survivalHazard Ratiop-value95% CIChemotherapy0.6020.0020.435-0.834Age (years)1.0510.0001.030-1.072Tumor size (mm)1.0170.0001.012-1.022Stage N11.9090.0001.488-2.450Stage N24.8550.0011.978-11.916Stage N31.9060.5210.266-13.637Grade 21.0140.9790.365-2.813Grade 31.6220.3400.601-4.374Charlson score1.1940.0570.995-1.433 Citation Format: Slavica Janeva, Chenyang Zhang, Anikó Kovács, Toshima Z Parris, Anna-Karin Tzikas, Christopher M Pezzi, Riccardo A Audisio, Roger Olofsson Bagge. Adjuvant chemotherapy in elderly women with triple-negative breast cancer: Swedish registry data 2009-2017 [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P2-14-05.

The role of neoadjuvant chemotherapy in elderly patients with borderline or locally advanced pancreatic cancer: Is it safe and feasible?

685 Background: For borderline resectable (BRPC) or locally advanced pancreatic cancer (LAPC), neoadjuvant (NAT) FOLFIRINOX or gemcitabine plus nab-paclitaxel (GnP) are standard treatment options and these regimens have shown a survival advantage over single-agent gemcitabine. However, the role of these modern therapeutic regimens in elderly patients is debatable. In this analysis, we evaluated the outcomes of neoadjuvant treatment (NAT) with combination chemotherapy in elderly patients. Methods: 230 consecutive patients who underwent neoadjuvant treatment for BRPC/LAPC discussed and planned for NAT at the University of Colorado Cancer Center from January 2011 to March 2019 were reviewed. 214 patients who received FOLFIRINOX (n = 143) or GnP (n = 71) were eligible for analysis. We divided all patients into three groups ( &lt; 70, 70-74, ≥75 years) and compared the short-term and long-term outcomes. Results: Of 214 patients, patients &lt; 70 (n = 147) received FOLFIRINOX more frequently than the other groups (p &lt; 0.001): FOLFIRINOX: 115 cases, GnP: 32 cases, 70-74 years (n = 33): FOLFIRINOX: 15 cases, GnP: 18 cases, and ≥75 years (n = 34): FOLFIRINOX: 13 cases, GnP: 21 cases. Resection rates were not statistically different between three groups ( &lt; 70: 62%, 70-74: 70%, ≥75 years: 56%, p = 0.504). There was a slight trend towards worse survival in the two older groups (Median Survival Time [MST]: &lt; 70: 23.2 mo., 70-74: 19.5 mo., ≥75 years: 17.6 mo., p = 0.075) The FOLFIRINOX group was superior to GnP group in all three groups (MST: &lt; 70: 25.6 vs 18.2 mo., p = 0.017; 70-74: 33.2 vs 16.1mo., p = 0.029; ≥75 years: not reached vs 16.1 mo., p = 0.135). There were no toxic deaths or 30 day mortality after pancreatectomy in the study population. Conclusions: Neoadjuvant combination chemotherapy regimens were safe and feasible for elderly patients. Neoadjuvant therapy with FOLFIRINOX was associated with a survival advantage vs GnP and is an good option for fit and elderly patients ≥75 years.

The Influence of Patients' Age on the Outcome of Treatment for Pancreatic Ductal Adenocarcinoma.

The aim of the study was to determine the impact of age on curative management and outcomes of patients with pancreatic ductal adenocarcinoma. Patients who underwent resection for pancreatic ductal adenocarcinoma at 2 units were retrospectively reviewed (between 2005 and 2017) and stratified by age (older patients ≥70 years). Regression analysis was used to explore factors impacting administration of adjuvant chemotherapy and survival. The Kaplan-Meier method was used to estimate overall survival (time from surgery to death). Statistical significance was set at P < 0.05. From 2005 to 2014, 222 patients were identified (<70 years, n = 128; ≥70 years, n = 94). Elderly patients were less likely to receive adjuvant chemotherapy compared with younger patients (odds ratio, 0.57, P = 0.041). Tumor stage, margin, and year of surgery (post-2011 vs pre-2011) were not predictors for chemotherapy receipt (P > 0.05). Frailty was the commonest reason (36.8%) to decline chemotherapy in elderly patients. In patients receiving adjuvant chemotherapy, completion rates (P = 0.32) and overall survival (24 months vs 30 months, P = 0.50) were no different. Elderly patients demonstrate similar outcomes to younger yet are less likely to commence chemotherapy because of frailty. Holistic preoperative assessment may improve selection for curative treatment.

Effect of Age on Laparoscopic Surgery and Postoperative Chemotherapy in Elderly Patients With Colorectal Cancer.

Purpose We aimed to evaluate the postoperative complications of laparoscopic colorectal cancer (CRC) surgery and the adverse events of postoperative chemotherapy in elderly patients compared to younger patients and to identify the factors influencing the termination of postoperative chemotherapy.Methods Between June 2015 and May 2018, 188 patients with CRC underwent laparoscopic surgery with curative intent. Patients aged ≥ 70 were defined as elderly. Postoperative complications and adverse events of chemotherapy were assessed by using the Clavien-Dindo classification and the Common Terminology Criteria for Adverse Events, respectively. The clinicopathological factors were analyzed retrospectively.Results Seventy-eight patients were considered elderly with a mean age of 77.5 ± 5.5 years. Overall postoperative complications occurred in 68 patients (36.2%). Age and primary tumor location were independent predictors of overall postoperative complications. Smoking history was the only independent predictor of major postoperative complications. Of 113 patients who were recommended postoperative chemotherapy, 90 patients (79.6%) received postoperative chemotherapy. Overall adverse events occurred in 40 patients (44.4%). The American Society of Anesthesiologists physical status classification and chemotherapy regimen were significantly associated with overall adverse events. The chemotherapy regimen was the only factor significantly associated with severe adverse events. Of 90 patients, postoperative chemotherapy could not be completed in 11 (12.2%). Age was the only factor significantly associated with stopping postoperative chemotherapy (P = 0.003).Conclusion This study shows that laparoscopic CRC surgery and postoperative chemotherapy were feasible in elderly patients. Further efforts are needed to ensure that elderly patients have the opportunity to make informed decisions regarding postoperative chemotherapy.

Impact of timing of chemotherapy for pancreatic cancer in the elderly: A national cancer database study

Presenter: Neha Lad MD | Miami Cancer Institute Background: Recent reports have confirmed that chemotherapy improves overall survival in patients with pancreatic cancer. The aim of this study is to specifically evaluate the effect of timing of chemotherapy on overall survival of elderly patients undergoing pancreatic surgery for pancreatic adenocarcinoma (PDAC). Methods: The NCDB was reviewed from 2004 to 2016. The effect of chemotherapy in elderly patients (≥75) was studied. Three major groups were analysed: adjuvant (ADJ), neoadjuvant (NEO) and neoadjuvant with adjuvant (BOTH). Chi-square test was used to find differences in patient characteristics between groups. Log rank test and multivariable Cox proportional regression models were used to find factors associated with survival. Results: A total of 380,524 patients were diagnosed with pancreatic adenocarcinoma during the study period. Of these, 130,039 were ≥75 years of age, which included 18,291 patients (7.1%) who underwent surgical treatment. Chemotherapy was provided as follows: 5,640 underwent adjuvant chemotherapy (ADJ), 888 neoadjuvant chemotherapy (NEO) and 345 received at least 2 cycles before, but also received chemotherapy after (BOTH). There was a significant difference in the proportion of patients with Stage I to IV between groups, with a majority being diagnosed at stage II patients in NEO (48%) and BOTH (53%) . Demographics and Charlson-Deyo comorbidity score were similar across the groups. The 3 year survival rate was 31.9% in BOTH (95% CI: 26.4 - 38.6), 24.7% in NEO (95% CI: 21.6 - 28.3) and 25.0% in ADJ (95% CI: 23.8-26.3). Univariate Cox regression shows a significantly improved survival in BOTH in comparison to ADJ (p=0.0081) and a trend in improvement in comparison to NEO (p=0.079). There was a non significant tendency to improved survival when comparing elderly patients that received only neoadjuvant vs those that received only adjuvant (p=0.23). On multivariate analysis comorbidities were identified as an independent factor negatively impacting survival. Chemotherapy given as BOTH was independently associated with improved survival (figure 1). Conclusion: Elderly surgical patients undergoing BOTH neoadjuvant and adjuvant chemotherapy had improved survival when compared to patients receiving chemotherapy only in an adjuvant setting. Therefore, BOTH should not be withheld in elderly patients just because of their age.

Effectiveness of continuous monitoring by activity tracker of patients undergoing chemotherapy for urothelial carcinoma

BackgroundIt is difficult to objectively evaluate chemotherapy-related adverse events early in elderly patients with urothelial carcinoma. A delayed response causes a reduction in quality of life (QoL). Wearable activity systems that objectively record life logs have recently been used. ObjectivesThis study was undertaken to verify the reliability and effectiveness of a wearable activity system (Fitbit) to monitor subjective symptoms in an objective manner during chemotherapy for elderly patients with urothelial cancer (UC). Materials and MethodsThis was a cohort prospective study. Elderly patients with UC were enrolled who received short hydration gemcitabine and cisplatin (shGC) combination therapy at Nagoya City University Hospital from January 2018 to March 2020. A Fitbit was used to monitor heart rate, distance moved, and cardio zone time. Heart rate was also monitored by an oscillometric method. The relationship between Fitbit recordings and perceived adverse events, such as fatigue, constipation and nausea, observed during chemotherapy was investigated using a general linear mixed effects model. ResultsTwenty-one of 28 inpatients were enrolled and observed for a total of 824 days. A significant, moderately strong correlation was found between two measurements of heart rate (Pearson's r = 0.65, p < 0.05). The measurement of fatigue using Fitbit was effective (p = 0.03). ConclusionFitbit monitoring can measure the QoL of a patient and was useful for monitoring elderly patients with UC undergoing shGC therapy in an outpatient setting. Fitbit may be useful for monitoring outpatients and their QoL during chemotherapy.

Comparative Study of the Safety and Efficacy of First-Line Cisplatin and Carboplatin Chemotherapy in Elderly Patients with Metastatic Urothelial Carcinoma

Objectives: Platinum-based chemotherapy is the standard treatment for metastatic urothelial carcinoma (mUC). However, considering elderly patients often experience comorbidities and frailty, the utility of cisplatin-based chemotherapy for elderly patients is still debatable. We conducted this study to compare the safety and efficacy of carboplatin and cisplatin in elderly patients with mUC. Methods: This retrospective study enrolled elderly patients with mUC (defined as aged ≥70 years) who underwent first-line platinum-based chemotherapy between September 2001 and October 2018. The primary endpoints were chemotherapy-related adverse events (AEs), including treatment-related hospitalization or death. The secondary outcomes were overall survival (OS) and progression-free survival calculated by Kaplan-Meier analysis. Results: In total, 108 elderly patients with mUC were enrolled and allocated into the cisplatin or carboplatin group. Patients treated with carboplatin-based chemotherapy had a significantly higher incidence of all grade ≥3 AEs (78.8 vs. 50.0%, p = 0.008) than those on cisplatin. AE-related hospitalization (47.5 vs. 19.1%, p = 0.002) and treatment-related death (17.5 vs. 4.4%, p = 0.02) were significantly increased in the carboplatin group. In the univariate analysis, the median OS in the cisplatin group was significantly increased compared with the carboplatin group (13.6 vs. 7.2 months, p = 0.045). The Cox multivariate regression model indicated that leukocytosis (HR 3.17, 95% CI 1.84–5.46, p < 0.001) and anemia (HR 2.02, 95% CI 1.11–3.65, p = 0.02) were independent prognostic factors. Conclusion: Elderly patients with mUC treated with cisplatin-based chemotherapy had better survival and safety profiles than those treated with carboplatin. Age itself was not a crucial factor in determining cisplatin eligibility.

CtDNA After Chemotherapy in Elderly Patients With Acute Leukemia

CtDNA After Chemotherapy in Elderly Patients With Acute Leukemia

516P - Clinical outcomes in elderly patients with advanced non-small cell lung cancer: A prospective multicenter study of the National Hospital Organization in Japan

BackgroundPrevious studies have developed risk stratification schemas to assess chemotherapy toxicity. However, the geriatric assessment variables that should be used to assess the individual risk of severe chemotherapy toxicity and clinical outcomes in elderly patients remain controversial. MethodsPatients aged ≥70 years with advanced non-small cell lung cancer (NSCLC) who were treated at 24 National Hospital Organization institutions and completed a pre- first-line chemotherapy assessment were included in this study. The assessment included the following: patient characteristics, treatment variables (platinum doublet: PD, single agent: SA, tyrosine kinase inhibitor: TKI), laboratory test values, and geriatric assessment variables. We analyzed the correlations between each factor and clinical outcomes of chemotherapy and overall survival (OS). ResultsIn total, 348 patients with advanced NSCLC, with a median age of 76 years (range, 70 to 95 years), joined this prospective study. In all patients, the best objective response rate and disease control rate were 35.6% and 81.0%, respectively. The median progression-free survival (PFS) and OS were 6.1 and 16.5 months, respectively. Performance status, treatment variables, and several laboratory test results (anemia, albumin, and C-reactive protein) affected the best response of chemotherapy (p = 0.0249, <0.001, <0.001, <0.001, and <0.001 respectively, between disease control and progressive disease cohorts). These factors also affected the PFS of first-line therapy (5.8 (PD) vs 3.5 (SA) vs 10.5 (TKI), and 2.9 vs 6.4, 2.9 vs 6.3, 3.0 vs 6.5, 3.0 vs 7.0 months respectively, between above or below each cutoff cohort) and OS (13.7 (PD) vs 10.4 (SA) vs 30.6 (TKI), and 7.0 vs 16.8, 6.3 vs 16.8, 6.6 vs 17.8, 6.2 vs 18.1 months, between above or below each cutoff cohort). ConclusionsPerformance status, treatment variables, and several laboratory test values independently predicted clinical outcomes of chemotherapy in elderly patients with advanced NSCLC. Clinical trial identificationUMIN000010384. Legal entity responsible for the studyNational Hospital Organization. FundingNational Hospital Organization. DisclosureAll authors have declared no conflicts of interest.

Adjuvant Chemotherapy in Elderly Patients with Early-stage Non-small Cell Lung Cancer

Adjuvant Chemotherapy in Elderly Patients with Early-stage Non-small Cell Lung Cancer

Major adverse events and prognostic factors in elderly patients with cervical cancer undergoing intensive-modulated radiotherapy combined with intravaginal brachytherapy

Objective To investigate the adverse effects and clinical efficacy of the intensive modulated radiotherapy(IMRT)and intravaginal brachytherapy combined with versus without chemotherapy in elderly patients with cervical cancer, and to analyze its prognostic factors. Methods Clinical data and follow-up results of 214 patients with cervical cancer aged ≥60 years undergoing IMRT and intravaginal brachytherapy combined with or without chemotherapy were retrospectively analyzed.The overall survival(OS)rate was calculated by using the Kaplan-Meier method.Prognostic factors were analyzed by Log-rank single factor test and Cox multivariate analysis. Results The rates of myelosuppression(≥grade 3)was higher in the concurrent chemo-radiotherapy group than in simple radiotherapy group(48.6% vs.15.8%, χ2=27.372, P<0.05). The complete response(CR)rate was higher in the concurrent chemo-radiotherapy group than in the simple radiotherapy group(83.0% vs.68.3%, χ2=5.993, P=0.014). The 1-, 3- and 5-year OS rate were 92.2%, 79.3% and 65.6%, respectively in all patients.Univariate analysis showed that the staging, lymph node metastasis status, pathological type and short-term efficacy of cervical cancer(based on FIGO guideline)were influencing factors for the prognosis(χ2=4.321-30.316, all P<0.05). Multivariate analysis showed that the FIGO staging, lymph node metastasis status and short-term efficacy were independent influencing factors for the prognosis(χ2=5.284-14.261, all P<0.05). Conclusions The intensive modulated radiotherapy and intravaginal brachytherapy combined with chemotherapy have a good efficacy and favorable long-term survival rate for the treatment of cervical cancer in elderly patients, and its major adverse effects can be tolerated.The FIGO staging, lymph node metastasis status and short-term efficacy are independent influencing factors for the prognosis in elderly patients with cervical cancer. Key words: Uterine cervical neoplasms; Radiotherapy; Prognosis

1571P - Predicting chemotherapy toxicity in elderly patients with advanced non-small cell lung cancer: A prospective multicenter study of the National Hospital Organization in Japan

BackgroundPrevious studies have developed risk stratification schemas to assess chemotherapy toxicity. However, it is controversial which geriatric assessment variables should be used to assess the individual risk of severe toxicity from chemotherapy in elderly patients. MethodsPatients aged ≥70 years with advanced non-small cell lung cancer (NSCLC) treated at 24 National Hospital Organization institutions completed a pre-1st-line chemotherapy assessment, including the following: patient characteristics, treatment variables, laboratory test values, and geriatric assessment variables. Patients were followed through one cycle of chemotherapy to assess grade 3 (severe) to grade 5 (death) adverse events according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0. We also analyzed clinical outcomes of all patients. ResultsIn total, 348 advanced NSCLC patients with a median age of 76 years (range, 70 to 95 years) joined this prospective study. In all patients, the best objective response rate and disease control rate were 35.6% and 81.0%, respectively. Severe adverse events ≥grade 3 occurred in 136 patients (39.1%). Functional status (performance status, daily life independence level, and Barthel index; p=0.0037, 0.0023, and 0.0214, respectively, between the ≥grade 3 cohort and the grade 0-2 cohort) and laboratory test results (anemia, albumin, and lactate dehydrogenase; p=0.0497, 0.0171, and 0.0060 respectively, between the ≥grade 3 cohort and the grade 0-2 cohort) affected the occurrence of severe non-hematologic adverse events. For hematologic adverse events, body mass index, Charlson comorbidity, daily life independence level, recognition status, treatment variables, and anemia were involved with the occurrence of severe adverse events (p=0.0488, 0.0333, 0.0358, 0.0276, < 0.0001, and 0.0271, respectively, between the ≥grade 3 cohort and the grade 0-2 cohort). ConclusionsGeriatric assessment variables and several laboratory test values independently predicted vulnerability to chemotherapy in elderly patients with advanced NSCLC. Clinical trial identificationUMIN000010384. Legal entity responsible for the studyThe National Hospital Organization in Japan. FundingThe National Hospital Organization in Japan. DisclosureAll authors have declared no conflicts of interest.

1573P - Weekly epirubicin as palliative treatment in elderly patients with malignant pleural mesothelioma

BackgroundMalignant pleural mesothelioma (MPM) is a rapidly progressive tumor with a poor prognosis. The benefit of first-line standard pemetrexed – platinum chemotherapy in MPM has been established. Currently, second-line chemotherapy is increasingly use, because many patients are fit at the progression of the disease. No standard second/further line chemotherapy exit for MPM after failure of first-line pemetrexed based chemotherapy. This study aimedat evaluating the clinical activity of weekly epirubicin as second/further line chemotherapy in elderly patients with MPM. MethodsFrom July 2014 to March 2018, in Medical Oncology Department of Asst-rhodense Hospital, 22 patients (15 males and 7 females with a median age of 78 years, range 74-86) with MPM were eligible for analysis. Histology was epithelioid in 17 pts, sarcomatoid in 3 and biphasic in 2 patients. A Carboplatin-(AUC:4) pemetrexed doublet was administered in 14 pts and 8 pts received gemcitabine as single agent how first-line. Gemcitabine was given as second-line in 9 pts. Epirubicin was always administered with the same schedule at 20mg/m2day 1, 8, 15 every 28 until disease progression/intolerance. ResultsOverall response rate was as follows: 4 PR (18 %), 10 SD (45 %) and 8 PD (40%). Median time to progression was 5 months (range 3 – 11). No life threatening event occurred. No grade 3-4 toxicities were observed. Liver toxicity grade 1-2 in 2 pts (10%), thrombocytopenia grade 1 in 2 pts (9%), neutropenia grade 1-2 in 8 pts (40 %), fatigue grade 2 in 7 pts (32%), nausea grade 1 in 4 pts (20%). ConclusionsEpirubicin has a modest clinical activity in pre-treated elderly patients with MPM in progression after one or two regimens, with an acceptable toxicity profile. It could be considered as a palliative treatment. Legal entity responsible for the studyThe authors. FundingHas not received any funding. DisclosureAll authors have declared no conflicts of interest.